A Hybrid Effectiveness-Implementation Trial of Group CBT in Urban Schools

NCT02651402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2021-04-08

No results posted yet for this study

Summary

Unresolved psychological problems, such as anxiety, affect a significant number of our students and interfere with their ability to attend, actively participate, and prosper in school. This project will expand the capacity of selected mental health agencies to provide services in the participating schools through school therapeutic services (STS). The project will provide enhanced training in evidence-based behavioral health interventions to school-based mental health providers. The services will be implemented by STS Bachelor's or Master's level therapists supervised by their mental health agency supervisors (Internal Support), who are in turn supported by the research team (Train-the-Trainer) or external consultants (Train the Trainer+).

Conditions

  • Anxiety Disorders

Interventions

BEHAVIORAL

FRIENDS for Life

Friends for Life (FRIENDS): FRIENDS, a GCBT program, is an effective program for the prevention and treatment of anxiety disorders in children evidenced by a meta-analysis on school-based interventions for at-risk and clinically anxious youth. FRIENDS was developed based on the view that anxiety is a tripartite construct involving physiological, cognitive, and behavioral components. Core Intervention components: Experts in CBT for childhood anxiety disorders have identified 5 essential components: psychoeducation, somatic management skills training, cognitive restructuring, exposure methods, and contingency management. The FRIENDS protocol consists of 10 weekly sessions and two booster sessions. We included the booster sessions in the regular protocol for a total of 12 sessions.

BEHAVIORAL

Adapted FRIENDS

Adapted Friends (aFRIENDS): We conducted planned adaptations to the FRIENDS protocol based on our collective experience with the protocol and qualitative data (focus group and interviews). We followed procedures developed by Lee and colleagues, including surveying service providers and trainers regarding the appropriateness of FRIENDS for the target population. Changes were made to the language (idioms, metaphors, words), cultural fit (cultural values), methods (session length, number of sessions), activities (in-session practices), which resulted in additions and substitutions in these areas while maintaining the 5 essential components of the treatment. aFRIENDS is a briefer (8-session) and more engaging and culturally-sensitive protocol than FRIENDS.

BEHAVIORAL

Train-the-Trainer

Train the Trainer (TT): agency supervisors are trained to conduct effective supervision (one initial training and 2 booster sessions), and then go on to train intervention therapists.

BEHAVIORAL

Train-the-Trainer Plus

Train the Trainer Plus (TT+): a modified train-the-trainer approach by which supervisors receive training plus extended on-going consultation on conducting effective supervision with intervention therapists.

Sponsors & Collaborators

Principal Investigators

  • Ricardo B Eiraldi, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02651402 on ClinicalTrials.gov